Enteric coating pellet of proton pump inhibitor

An enteric-coated pellet and proton pump technology, which is used in the delivery of pills, medical preparations containing active ingredients, and the digestive system, can solve the problems of low in vitro release and rise of related substances, and achieves improved in vitro release and improved The effect of stability, good business prospects

Active Publication Date: 2013-10-09
珠海润都制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Aiming at the problems of low in vitro release rate and significant increase of related substances during storage of the above-mentioned pharmaceutical composition containing proton pump inhibitors, the present invention provides a method for improving the in vitro release rate and stability of the pharmaceutical composition of proton pump inhibitors, And the preparation process of the proton pump inhibitor pharmaceutical composition based on the method

Method used

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  • Enteric coating pellet of proton pump inhibitor
  • Enteric coating pellet of proton pump inhibitor
  • Enteric coating pellet of proton pump inhibitor

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] The processing of embodiment 1 calcium carbonate micronization

[0028] Take by weighing 50Kg of calcium carbonate coarse powder of 80 mesh sieves, put gas into MQL03 jet mill (manufactured by Weifang Erpai Powder Technology Equipment Co., Ltd.) for micronization, and pass through a 325-mesh sieve to obtain micronized calcium carbonate 42.3 Kg, the yield is 84.6%. Get the micronized calcium carbonate sample and detect it with a Mastersizer2000 Malvern laser particle size analyzer (manufactured by Malvern Instruments, UK), and the D90 is 30.7um.

Embodiment 2

[0029] The processing of embodiment 2 magnesium carbonate micronization

[0030] Take by weighing 50Kg of magnesium carbonate coarse powder of 80 mesh sieves, put it in an MQL03 jet mill (manufactured by Weifang Erpai Powder Technology Equipment Co., Ltd.) for micronization, and pass through a 300 mesh sieve to obtain micronized magnesium carbonate 42.3 Kg, the yield is 84.6%. Get the micronized magnesium carbonate sample, and detect it with a Mastersizer2000 Malvern laser particle size analyzer (manufactured by Malvern Instruments, UK), and the D90 is 45.2um.

Embodiment 3

[0031] The processing of embodiment 3 calcium hydroxide micronization

[0032]Weigh 50Kg of calcium hydrochloride coarse powder through a 80-mesh sieve, put it into an MQL03 jet mill (manufactured by Weifang Erpai Powder Technology Equipment Co., Ltd.) for micronization, and pass through a 200-mesh sieve to obtain micronized hydrogen Calcium oxide 45.9Kg, yield is 91.8%. Take the micronized calcium hydroxide sample and detect it with a Mastersizer 2000 Malvern laser particle size analyzer (manufactured by Malvern Instruments, UK), and the D90 is 68.7um.

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Abstract

The invention discloses an enteric coating pellet of a proton pump inhibitor. The enteric coating pellet comprises a blank pellet core, a drug carrying layer, an isolating layer and an enteric layer. The enteric coating pellet is characterized by comprising at least one alkali compound, wherein the weight of the alkali compound does not exceed 5% of the total weight of the pellet; the grain size D90 of the alkali compound is not greater than 75 microns. The enteric coating pellet preparation provided by the invention is capable of reducing the adsorption effect of the alkali compound to the drug and improving the release degree in vitro of the drug, and also capable of improving the alkalinity of the surrounding environment of the proton pump inhibitor and enhancing the stability of the drug.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to the preparation of a proton pump inhibitor enteric-coated pellet. Background technique [0002] Proton pump inhibitors are benzimidazole compounds used for the treatment of peptic ulcer, esophageal reflux disease, gastrinoma syndrome and Helicobacter pylori. So far, proton pump inhibitors that have been marketed abroad include omeprazole, esomeprazole, pantoprazole, lansoprazole, rabeprazole, dex-rabeprazole, dex-lansoprazole azoles, etc. The proton pump inhibitors listed in China include omeprazole, esomeprazole, pantoprazole, lansoprazole, rabeprazole, etc., and dex-rabeprazole, Dexlansoprazole, etc. Omeprazole was launched in the United States in 1988 and is the earliest benzimidazole proton pump inhibitor on the market. [0003] Instability is a common feature of this type of compound, such as being easily degraded under conditions such as light, heat, acid, and oxidation, r...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K9/20A61K9/48A61K31/4439A61P1/04
Inventor 谢斌周爱新莫泽艺李必禄张志刚杨刘增吴杰文陈茵茵
Owner 珠海润都制药股份有限公司
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